Friday, October 27, 2006

Biomarkers and Alcohol

Following up on Kim's excellent post below on drug courts, Ben Barlyn from NJ has forwarded us this letter he got that directly affects drug courts as well as the "technocorrections" focus we've had here. Thanks again, Ben.

On September 25, 2006, the U.S. Department of Health and Human Services released the attached Substance Abuse Treatment Advisory entitled: "The Role of Biomarkers in the Treatment of Alcohol Use Disorders". NADCP is disseminating this advisory to keep drug court practitioners current on the state of the science associated with ethyl glucuronide (EtG) testing and its use in alcohol abstinence monitoring. The advisory contains the following guidance:"Currently, the use of an EtG test in determining abstinence lacks sufficient proven specificity for use as primary or sole evidence that an individual prohibited from drinking, in a criminal justice or a regulatory compliance context, has truly been drinking. Legal or disciplinary action based solely on a positive EtG, or other test discussed in this Advisory, is inappropriate and scientifically unsupportable at this time. These tests should currently be considered as potential valuable clinical tools, but their use in forensic settings is premature."The fact that SAMHSA's Center for Substance Abuse Treatment (CSAT) was reviewing the interpretation and utilization of EtG testing results comes as no surprise. However, the stark conclusions rendered in this guidance document will likely come as a shock to many drug court professionals. Since its introduction and commercial availability, within the last couple of years, ethyl glucuronide (EtG) testing has become widespread. The conclusions of the SAMHSA advisory will undoubtedly have a significant chilling effect on the continued use of this alcohol abstinence-monitoring tool.This advisory concludes that the science of EtG testing - our capability to employ highly sensitive testing procedures to detect recent ethyl alcohol exposure - has outpaced our ability to appropriately interpret the test results in a forensically defensible manner. The conclusions expressed by SAMHSA are not the result of inherent flaws in the testing science for EtG, but rather in our inability to interpret those results in a way that allows the reliable differentiation as to the source of the alcohol - consumption versus unintended exposure. CSAT, through its National Advisory Council, has concluded that there is inadequate research data about the populations being tested to evaluate an "individual's likely exposure to products containing nonbeverage alcohol, and the consequences for the individual and society of the individual's being erroneously labeled."Ethyl alcohol is ubiquitous in our environment. A very brief list of sources - medicines, foods, beverages, personal care products, cleaners, herbal preparations, etc. There is currently insufficient information to assess the degree to which any one of these sources (or indeed, a combination of sources) can result in the incidental exposure to ethyl alcohol and the subsequent production and identification of EtG in urine.For some time, many of us in the scientific community have been urging programs utilizing ethyl glucuronide testing to set the cutoff concentration high enough to avoid the potential of "innocent positive" results from inadvertent or environmental alcohol exposure. Unfortunately, the lure of the highly sensitivity EtG test combined with attempts to obtain "zero-tolerance" monitoring led many to ignore the risks despite mounting concerns. Many programs (mostly non-drug court related) continued to apply the 100 ng/mL cutoff that has undoubtedly led to inappropriate license revocations, unwarranted job dismissals and imprisonment of innocent persons. On August 12, 2006, the Wall Street Journal in a front-page article on EtG featured the following headline; "A new screen detects Sunday's gin in Monday's urine but it may be ensnaring some innocent people too." In the face of perceived injustices, adverse publicity and the misuse of EtG testing results, SAMHSA has taken a hard line regarding the on-going use of these analyses for criminal justice and forensic purposes.

The advisory will be viewed by many drug courts as rendering any EtG result as legally inadmissible for the purposes of client sanctioning. However, it would be unfortunate if programs abandon EtG testing altogether. Ethyl glucuronide remains an effective alcohol abstinence monitoring tool that permits rapid therapeutic intervention.In conclusion, drug courts are strongly urged to review this advisory and assess its impact on current policies and procedures related to the monitoring of clients for alcohol usage via EtG testing. As the advisory concludes, until further research enhances our understanding of the test's positive predictive value and the potential sources of false positives, caution is advised when interpreting EtG testing results. NADCP will keep you informed of future research findings and their impact on court proceedings.Paul L. CaryDirectorToxicology & Drug Monitoring LaboratoryUniversity of Missouri Health CareColumbia , Missouri

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